On Feb. 22, 1999, Texas issued a memorandum enforcing its rules on distributing nutraceuticals in the state. Any substance that has not been granted GRAS (Generally Recognized As Safe) status for animal use can’t be sold directly to horse owners. You must get it through your veterinarian. If this policy goes nationwide, it could reduce our right to feed supplements and the number of supplement choices available and would in all likelihood drastically raise the prices of these already costly products.
The Texas memorandum includes products we use every day — including joint nutraceuticals, any herbal, MSM, yucca, vitamin C — virtually anything that is not listed as an essential nutrient by the NRC or granted GRAS status by AAFCO (Association Of American Feed Companies). Veterinarians are also prohibited from placing nutraceuticals on display and may be required to submit proof that a valid patient-client-doctor relationship exists (e.g. your latest bill) to prove they should be permitted to sell you a supplement.
Why All The Fuss’
Human dietary supplements are regulated through the Food, Drug and Cosmetic Act and the 1994 Dietary Supplement Health and Education Act (DSHEA). But for equine supplements regulation is simpler: There essentially isn’t any.
Truthfully, the FDA has its hands full already, and equine supplements and feeds are pretty much left alone except for annual plant inspections. Therefore, individual states must put forth their own regulations, using existing federal laws and AAFCO recommendations (AAFCO can’t make laws).
Texas’ decision is extreme but not surprising. Texas is notorious for being tough on supplement manufacturers, as are a handful of other states, including Kentucky.
On one level, some supplement manufacturers brought this situation on themselves. The FDA specifically prohibits claims that any supplement can cure, prevent, mitigate or treat a specific disease. Marketing a product for horses with arthritis or tying-up, for example, violates that law. Any product that makes such claims is considered a drug, regardless of its ingredients, and subject to new-drug approval proceedings.
How we, or manufacturers, might feel about the FDA label requirement (and it does have its benefits) is irrelevant. The fact is that it exists, and companies have been flagrantly violating it for a long time. When a high-profile violation comes along (see Lampley sidebar) that clearly poses a threat to the health and welfare of the horse, regulating bodies are likely to move on the question.
It’s also interesting that recent efforts have been mounted to make all human-dietary supplements prescription items. These efforts were indirectly spearheaded by pharmaceutical companies who would love to cash in on the tremendous supplement market.
Many supplements have health/medical benefits that either equal existing expensive prescription drugs or have benefits that are unique (St. John’s Wort for depression) or not offered by any prescription drug (magnesium for control of blood pressure and prevention of fatal complications of heart attacks).
Now that the question is on the table, there’s no turning back, although it may take years for coherent policy recommendations to appear. In the meantime, what happens to these products is up to the individual states.
A major problem is that, since dietary supplements for horses and other animals are not defined by federal law, they in essence don’t exist. Current classifications include only food, food additives and drugs. The closest match, because of the claims made for these products, is drugs. Unless manufacturers drop the drug claims, their products can legitimately be removed from the market.
Step one is for companies to do just that, and quickly. If they can claim to be a food, on the basis of content (protein, carbohydrate, fat, minerals), they need only to state which nutrients that “food” supplies and meet standards for clean manufacturing and consistent levels of those nutrients in the product. If they have to be classified as a food additive, they must meet both safety and efficacy criteria.
What is really needed, however, is a new classification, although AAFCO does not seem willing to accept this. These things need to be called something like “nonessential functional nutrients” to distinguish them from food additives that have no nutritional value. Claims should be tailored to match the biological/physiological effects of the supplement at the dosage used. Companies would then be forced to submit research to prove the product actually does such things as “improve oxygen utilization.” This would place them under tighter restrictions than human supplements, but that’s not necessarily a bad thing.
Another possibility would be for AAFCO to recommend they be classified as dietary supplements as defined by DSHEA and subject to the same regulations — primarily regarding purity, safety, appropriate manufacturing, inclusion of expiration dates, guaranteed potency, data on stability of the product. We wouldn’t know any more about whether the things actually work, but we would be guaranteed a high-quality product — a major improvement.
We don’t want to lose our rights to feed supplements to our horses as we see fit. The action taken by Texas is extreme. Many of the supplements in danger of being banned have a long, clear history of being beneficial. Their withdrawal would be an unnecessary loss that is unjustified on the grounds of concern regarding safety for animals or humans consuming animal products.
While we applaud the AAFCO decision to tackle the difficult subject of nutraceuticals and agree that issues need to be resolved, the fact remains that AAFCO is not a regulatory agency.
Placing all sales and distribution in the hands of veterinarians, many of whom don’t want it and freely admit no more specific knowledge about these products than the average owner or trainer, is not a workable solution.
AAFCO definitions and GRAS assignments are to guide legislation, not replace it. We need an animal/veterinary DSHEA equivalent.
There further needs to be a division between herbals and other nutrients that are clearly intended as dietary supplements, with at least some herbals logically falling under the expertise of the FDA/CVM (Center For Veterinary Medicine) because of their pharmacological actions. We believe AAFCO should work in conjunction with the FDA toward establishing a policy.